The following data is part of a premarket notification filed by Nsi with the FDA for Sc Tip Cleaner.
Device ID | K120581 |
510k Number | K120581 |
Device Name: | SC TIP CLEANER |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | NSI 611 WEST 5TH ST Austin, TX 78701 |
Contact | Gordon Wehner |
Correspondent | Gordon Wehner NSI 611 WEST 5TH ST Austin, TX 78701 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-27 |
Decision Date | 2012-06-29 |